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CTRI Number  CTRI/2025/06/088793 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 12/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   The impact of Regional anaesthesia and General Anesthesia for Below Knee Amputations on the length of stay in hospital after Surgery and other complications over 30 days after Surgery in a tertiary hospital in India. 
Scientific Title of Study   Impact of Regional and General Anaesthesia for Below knee amputations on duration of post operative hospital stay and associated 30 day post-operative outcomes – A retrospective cohort study in a tertiary hospital in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Natta Nehemiah Harshil 
Designation  Junior Resident 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia, Christian Medical College Vellore, Vellore - 632004 Tamil Nadu
Department of Anaesthesia, Christian Medical College Vellore, Vellore - 632004 Tamil Nadu
Vellore
TAMIL NADU
632004
India 
Phone  08220168658  
Fax    
Email  n.harshil@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Smitha Elizabeth George 
Designation  Professor 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia, Christian Medical College Vellore, Vellore - 632004 Tamil Nadu

Vellore
TAMIL NADU
632004
India 
Phone  04162282105  
Fax    
Email  smitha.lizgeorge@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Smitha Elizabeth George 
Designation  Professor 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia, Christian Medical College Vellore, Vellore - 632004 Tamil Nadu


TAMIL NADU
632004
India 
Phone  04162282105  
Fax    
Email  smitha.lizgeorge@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College Vellore 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  Department of Anaesthesia, Christian Medical College Vellore, Vellore - 632004 Tamil Nadu 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Natta Nehemiah Harshil  Christian Medical College Vellore  Department of General Surgery unit 1,2,3 and 4, Payl Brand building, Christian Medical College Vellore, Vellore
Vellore
TAMIL NADU 
08220168658

n.harshil@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (IRB) office of research Christian Medical College, Vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients undergoing elective and emergency Lower limb amputations pertaining to Below knee amputations. 
 
ExclusionCriteria 
Details  1.Patients already intubated prior to presenting to Operating Theatre
2.Patients undergoing other forms of amputations like Ray amputations.
3.Patients undergoing other surgical interventions along with the above mentioned amputations requiring General anaesthesia
4.Patients undergoing General anaesthesia combined with regional analgesia techniques (Epidural / Peripheral nerve blocks).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Impact of Anaesthetic technique (GA versus Regional) on post operative length of Hospital admission including ICU stay and other postoperative complications for patients undergoing lower limb below knee amputations  30 days post operative follow up of patients 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing Regional and General anaesthesia, Impact of sociodemographic and comorbidity variables on 30 day postoperative complications (mortality and morbidity).  30 days follow up of patients undergoing the procedure 
 
Target Sample Size   Total Sample Size="199"
Sample Size from India="199" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Lower limb amputations are regularly performed as a life saving surgeries in the underlying circumstances of sepsis, peripheral arterial disease or trauma. Peripheral vascular disease (PVD) and diabetes mellitus (DM) have been identified as primary risk factors for lower limb amputationsThe reasons for limb loss can be classified into the following categories: patient-specific issues such as comorbidities, presence of foot lesions, anatomical factors, and healthcare-related factors like access to healthcare and medical insurance. Indications for amputation are related to the degree of tissue necrosis or viability, and it is performable in either a single operation or a staged manner. In general, soft tissue quality and the ability to obtain bone coverage will guide the adequacy of the level of amputation. Patients who undergo LEA usually have comorbidities, including hypertension, heart failure, and end-stage renal disease and are likely to be in an older age group. Furthermore, these patients have advanced systemic atherosclerotic disease involving not only the peripheral limbs but also the coronary, cerebral, and renal circulations. Hence Anaesthetic management for such patients is chosen carefully. Because of ultrasound guidance, the usage of regional anaesthesia (RA) has increased since 2005. Additionally, compared to general anaesthesia (GA), RA has a number of physiological advantages, including as better stump flow, preservation of the body’s physiological reaction to stress, and comparable or greater analgesia following surgery.  Compared with GA, neuraxial anaesthesia, in particular, has been associated with lower 30-day mortality and decreased morbidity, less blood loss, fewer surgical site infections, and a decreased rate of admission to critical care services after elective total hip or knee arthroplasty. The aim of the study is to compare the impact of Regional Anaesthesia and General Anaesthesia on the Length of Hospital stay and mortality and morbidity of patients in the 30 day post-op period in Indian Setting

 
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